Dilator device

ABSTRACT

A dilator device comprising a first elongated member having a handle-forming portion at one end thereof and a dilating portion in front of said handle-forming portion which dilating portion has a greatly elongated cross-section, and a second elongated member confronting and extending generally parallel to said dilating portion of said first member and having a greatly elongated cross-section similar in shape and orientation to that of the dilating portion of said first member. Links interconnect the second elongated member and the dilating portion of the first member so the longitudinal shifting of the second elongated member will move the second member from a position immediately contiguous to the dilating portion of said first member to a position where it is spaced a relatively large distance therefrom. Operating means are connected to the rear end portion of the second member which means is engageable by the thumb of the hand grasping said handle-forming portion to shift the second member longitudinally.

United States Patent Giesy et al. 1 Nov. 28, 1972 DILATOR DEVICE Primary ExaminerChanning L. Pace [72] Inventors: Jerry D. Giesy, Portland 0mg 'gttorneyrwallenstem, Spangenberg, l-lattis and 9722s; Gordon E. Smith, Madison, "ampe Wis. 53703; Jack M. Schneider, [57] ABSTRACT e a glo- 870229, is. ,7

Medidyne Corporation, Chicago,

[73] Assignee:

Ill.

[22} Filed: April 10, 1970 [211 App]. No.: 27,362

[52] U.S. C1 ..128/345 [51] Int. Cl. ..A6lm 29/00 [58] Field ofSearch..128/17,18, 19,303.11, 303.12, 128/341, 342, 343, 344, 345; 46/17 [56] References Cited UNITED STATES PATENTS 3,565,661 2/1971 Reynolds ..128/20 1,559,737 11/1925 Bock ..128/345 1,928,893 10/1933 Hoard ..128/341 2,221,138 11/1940 Hendrickson ..128/341 FOREIGN PATENTS OR APPLICATIONS 13,378 1892 Great Britain ..128/17 A dilator device comprising a first elongated member having a handle-forming portion at one end thereof and a dilating portion in front of said handle-forming portion which dilating portion has a greatly elongated cross-section, and a second elongated member confronting and extending generally parallel to said dilating portion of said first member and having a greatly elongated cross-section similar in shape and orientation to that of the dilating portion of said first member. Links interconnect the second elongated member and the dilating portion of the first member so the longitudinal shifting of the second elongated member will move the second member from a position immediately contiguous to the dilating portion of said first member to a position where it is spaced a relatively large distance therefrom. Operating means are connected to the rear end portion of the second member which means is engageable by the thumb of the hand grasping said handle-forming portion to shift the second member longitudinally.

21 Claims, 13 Drawing Figures PATENTEU B 5 I972 sum 1 0F 2 V hwemons JERRY D. GIESY Gannon: SMITH 1/ JACK M. SCHNEIDER b M MLMQ a a Ar-rvs.

p we 2 mbfwfi E a E T: 6% a a m v /\|MI.- Q Q N m JN PATENTEDDEB 51972 3104712 sum 2 0Fv 2 DILATOR DEVICE This invention relates to an expandable device having its most important application in calibrating and dilating male and female urethra, although it also has application to calibrating and/or dilating, for example, parts of the vascular system and the esophagus, bile ducts, rectum and uterine cervix. Urethral dilation by such a device finds use, for example, in urethral strictures and spasm, nonspecific urethritis, and other inflammatory diseases of the urethra to increase lumen size for subsequent passage of operative instruments, in postoperative stenosis from urethral or paraurethral surgery and in various congenital anomolies.

In many dilating applications, the patient visits the doctor a number of times for a progressive dilation of the constricted passageway involved. During each visit, the doctor first desirably obtains a measure or calibration of the initial internal circumference of the passageway (measured in terms of a French size). He then dilates the passageway by inserting a dilating instrument in the passageway to stretch the same to a desired small degree. In subsequent visits, this procedure may be repeated to stretch the passageway a greater amount until the ultimate desired dilation is achieved. In these medical dilating procedures, it is of utmost importance that the doctor maintains a close and accurate control over the degree of dilation to avoid unnecessary injury or trauma to the passageway.

The calibrating and dilating devices heretofore developed come in a variety of forms. One form of dilating device comprises a set of straight or curved solid or hollow metal tapered sounds coming in various progressively increasing sizes. Such devices are cumbersome to use and the user has a restricted degree of feel" to the act of dilating the passageway. In addition, the use of such tapered sounds employs dilating forces that are generally those of wedging the tissue thus causing longitudinal stresses along the direction of the urethra or other passageway rather than the more desired radial forces necessary for efficient dilation with a minimum of tissue trauma. Another form of dilating device is a progressively expandable device. One such device heretofore developed having several features utilized in the most preferred form of the invention includes a pair of separate metal parallel bars with metal links pivotally connected to the same so the bars can be moved between contiguous and spaced apart positions by longitudinally shifting one bar with respect to the other. This previously developed dilator device is made of a large number of separate metal parts, such as pins, links and the like, making it difficult and very expensive to make in very small sizes (like French size 16) which are necessary for many applications. Also, the transverse cross-sectional shape of the bars of this device is such that the bars can readily pinch and catch portions of the wall of the urethra or other vessel being dilated when the dilator device is collapsed. Also, the construction thereof requires two hands to move the bars between contiguous and spaced apart positions, namely, one hand to grab an organ (such as the male penis) or part of the device and the other hand to actuate a lever. Such a construction does not give the operator a fine control and feel of the instrument which is most important in the safe and effective use thereof.

In accordance with one of the features of the invention, the problem of making an expandable parallel bar type dilator economically in very small sizes is overcome by making the separable bars and the hinged links extending therebetween as a single integral molded synthetic plastic part with the pivot points of the links formed by sharply reducing the thickness of the synthetic plastic material. The cost of the dilator device for even very small sizes can be thus reduced to a point where the device can be a one-use disposable unit. The metal expandable devices heretofore made are very expensive devices, costing in excess of dollars. The present invention can be made to sell for much less than the cost of cleaning and sterilizing a device (e.g. l to 2 dollars) so it becomes a disposable unit. Moreover, the dilator device of the preferred form of the invention is functionally superior to the best of the prior expandable devices.

In accordance with another aspect of the invention, the links are spaced relatively close together to form a cage for holding back loose tissue which could otherwise be caught between the bars when the same are collapsed. Moreover, the cross-sectional shape of the bars, rather than being semicylindrical in shape as in the case of the prior devices, is of rounded or oval shaped so that the points at which the bars come together when they are collapsed are located substantially inwardly of the longitudinal side margins of the bars, further to minimize the possibility of catching loose tissue between the bars.

A further and most important feature of the invention is the provision of a means for moving the parallel separable bars of the dilator device from relatively contiguous to spaced apart positions which enables the user easily to closely control the degree to which the bars are separated and to feel opposition to the separation thereof. This means most advantageously comprises a thumb-operated control member requiring only one hand to operate. The dilator device has a handle which is held in the palm of one hand with the thumb of the hand engaging the control member which is preferably pushed by the thumb to separate the bars. The degree of separation of the bars can form a rough linear function of the thumb movement if the control member is rotatably mounted on or attached to one of the bars and the other bar linked thereto is connected to the rotatable control member at a point behind the pivot axis thereof and near or along a longitudinal line passing through the pivot axis when the bars are contiguous. The fact that the dilator device is operated by the thumb gives the user a fine sensitivity in feeling the opposition to the separation of the bars, to prevent over dilation of the organ or vessel involved. Also, index markings can be placed on the control member which indicates to the user precisely the distance the bars are separated. The parallel bars preferably are the only separable portion of the dilator device and thus provides equal dilation for the full length thereof. Thus, the user can determine from the aforesaid index markings the distension of the narrowest portion of the organ or vessel involved, unlike other devices where different portions of the dilator device can have different cross-sections or otherwise provide different degrees of distension. The user of separable, rigid, parallel bars permits the placement of a separate nonexpandable curved guide nose on the end of one of the bars, which is of assistance in completing passage into the adult male, pediatric female and, on occasion, in adult females. The guide nose is made sufficiently flexible that, unlike the metal guide noses of prior dilating devices, it can readily follow irregular paths without damaging the passageway and without substantial tissue trauma.

It is desirable that the dilating portion of a dilating device have a minimum circumference with a maximum degree of expansion, so that it can be used with the smallest of passageways and for a large range of dilation ranges so one instrument can be used for most dilation applications. To this end, when the dilation device includes only two parallel bars, the dilating portion of each of the bars has a substantially elongated cross-section in a direction transverse to the direction of relative movement thereof, so the long dimension thereof is much more than twice the shorter dimension transverse thereto. When the bars are in their relatively contiguous positions, they occupy an overall elongated space whose long axis extends in a direction transverse to the direction of separation thereof and is at least about l.5 times as long and preferably about two or more times its short axis. In such case, when the bars are moved to a position where their outermost surfaces are separated a distance approximately equal to their width, the constricted passageway will be expanded to similar degrees in all directions.

The above and other features and advantages of the invention will become more apparent upon making reference to the specification to follow, the claims and the drawings wherein:

FIG. 1 is a side elevational view of a urethral dilator device constituting the most preferred form of the present invention, the device being shown in its fully expanded dilating position;

FIG. 2 is a plan view of the dilator device shown in FIG. 1;

FIG. 3 is a view of the dilator device of FIG. 1 when the same has been adjusted to its fully collapsed position;

FIG. 4 is a greatly enlarged transverse sectional view of the dilator device of FIG. 1, taken along section plane 44 therein;

FIG. 5 is a transverse sectional view through the dilator device shown in FIG. 3, taken along section plane 5-5 thereof;

FIG. 6 is a greatly enlarged fragmentary sectional view through the dilator device shown in FIG. 2, taken along section plane 6--6 therein when the dilator device is in its fully expanded condition;

FIG. 7 is a greatly enlarged sectional view of the portion of the dilator device shown in FIG. 6 when the same has been fully collapsed;

FIG. 8 is a greatly enlarged sectional view through a portion of the dilator device shown in FIG. 2, taken along section plane 8-8 when the device is in its fully expanded condition;

FIG. 9 is a greatly enlarged sectional view of the portion of the dilator device shown in FIG. 8 when the same is in a fully collapsed condition;

FIG. 10 is a greatly enlarged sectional view of the portion of the dilator device which controls the expansion and collapse thereof taken along section plane 10-10 in FIG. 3, and shows the manner in which the device is locked in its collapsed condition;

FIG. 11 is a greatly enlarged sectional view through another portion of the dilator device which controls the expansion and collapse thereof, taken along section plane 11-11 in FIG. 2, and shows the manner in which the control member thereof is rotatably supported.

FIG. 12 is a fragmentary exploded view, partially broken away, of the tip of the nose portion of the dilator device shown in FIGS. 1-3 and a filiform at tachment to be attached to the tip of the nose portion of the dilator device; and

FIG. 13 is a fragmentary view, partly broken away, showing the assembly of the filiform attachment and the tip of the nose portion of the dilator device.

The most preferred form of the invention shown in the drawings and identified by reference numeral 2 includes a main elongated member generally indicated by reference numeral 4 which has at one end thereof a longitudinally extending handle-forming portion 4a adapted to be grasped in the palm of a hand, a longitudinally extending dilator bar-forming intermediate portion 4b merging with the front end of the handle forming portion 4a, and a slightly upwardly curving tapered guide nose portion 4c which is sufficiently flexible in all lateral directions that it can readily pass around obstructions and other sharp bends in male and female urethra. The dilator device further includes a dilator bar 6 which confronts and extends parallel to the dilator bar-forming portion 4b of the main elongated member 4. The dilator bar 6 and dilator bar-forming portion 4b of the main elongated member 4 are interconnected by longitudinally spaced pivoted links 8. The ends of the links 8 are pivotally connected to the dilator bar 6 and the dilator bar-forming portion 41) of the main elongated member 4 to enable the same to be moved between relatively contiguous or collapsed and maximum spaced apart or expanded positions by the longitudinal shifting of the bar 6 relative to the main elongated member 4. In the collapsed condition of the dilator device, the vertical profile of the device as shown in FIG. 3 is an even profile where the tapered nose portion 40 merges more or less smoothly with the dilator bar 6 and the dilator bar-forming portion 4b of the main elongated member 4. When viewing the horizontal profile of the dilator device (FIG. 2), the nose portion 4c merges smoothly at all times with the dilator bar 6 and the dilator bar-forming portion 4!).

In the most advantageous form of the invention, the main elongated member 4, the dilator bar 6 and the links 8 and the hinged connections thereto at the ends of the links form a single integrally molded part, which greatly reduces the cost of manufacture of the same. An important feature of the dilator device is that the links 8 are spaced quite closely together so as to form a cage which inhibits or prevents loose tissue from entering the space between the dilator bar 6 and the dilator bar-forming portion 4b of the dilator device, so that upon collapse of the dilator device within a constricted passageway loose tissue will not be caught and pinched by the dilator device. A further minimizing of the chance of catching loose tissue is effected by rounding the side surfaces of the dilator device so that the confronting surfaces which come together upon collapse of the device are located inwardly of the side margins of the dilator device. This feature of the invention will be explained in more detail hereinafter.

The longitudinal shifting of the dilator bar 6 is most advantageously achieved by the use of a thumboperated control member 10 pivotally supported in the manner to be explained to the front end portion of the handle-forming portion 4a of the dilator device. The rear end of the dilator bar 6 is secured to the thumboperated control member 10 at a point offset from the pivot axis 11 (FIG. 11) of the control member so that rotation of the control member 10 will shift the dilator bar 6 longitudinally between the position where it is contiguous to the dilator bar-forming portion 4b of the main elongated member 4 and the position where it is spaced apart to a maximum degree as shown in FIG. 1. The rotatable control member 10 could be molded with the other parts of the dilator device just described. However, it is most convenient to make this control member 10 as a separate part which interfits with the other parts of the dilator device in a manner to be more fully explained hereinafter.

The control member 10 is positioned so that when the user grasps the handle-forming portion 4a in the palm of his hand, the periphery of the control member is within easy reach of the thumb of the user which by pushing on the outer periphery of the control member forwardly longitudinally shifts the dilator bar 6. For reasons to be explained, to give a maximum effective control over the movement of the dilator bar 6 when the dilator device is in .its collapsed condition shown in FIG. 3, the point of connection of the rear end of the dilator bar 6 to the control member 10 is along or adjacent a line passing through the pivot axis 11 of the control member and extending generally parallel to the length of the dilator device. In such case, when the thumb of the user engages the periphery of the control member and pushes forwardly thereon, for each incremental angular rotation of the control member 10 the dilator bar 6 will move a similar appreciable distance relative to the dilator bar-forming portion 4b of the main elongated member 4. (If the users thumb were to engage the rear end of the dilating bar directly, the transverse movement of the dilator bar would be a sinusoidal-like function of the degree of thumb movement rather than a near linear function thereof, as in the case with the use of a rotatable control member. The broad aspects of the invention, however, include the use of a direct'operation of the dilators bar.

To most conveniently mold the dilator bar 6, the links 8, and the main elongated member 4 as one integrally molded piece, these parts are molded with the dilator bar 6 spaced a maximum distance from the main elongated member 4. In such case, the resiliency of the synthetic plastic material out of which the device is made (which is most advantageously polyethylene or nylon) will urge the dilator device into its maximum expanded condition shown in FIG. 1. The resilient force which urges the dilator bar 6 to the position is, however, such a modest force that a constricted urethral or other passageway will easily force the device into its collapsed condition. Thus, the force applied by the users thumb against the control member 10 will operate against the collapsing force of the passageway involved so that the user can feel the opposition to the movement of the control member 10. The control member 10 has calibrated index marks 9 on the sides thereof which indicate the circumference in French size number of a passageway dilated by the device. The French size is identified by the number which is ad- 5 jacent to the upper surface of the handle-forming portion 4a of the main elongated member 4. Thus, in FIG. 1, the French size of the dilated vessel which is expanded by the dilator device shown in FIG. 1 will be French size 40.

Now that the general features of the dilator device 2 have been described, the particular preferred constructional details of the various parts thereof in the most preferred form of the invention will be described. Although the shape of the handle-forming portion 4a may vary widely, the vertical profile of the rear end portion 13 thereof to be held in the palm of the hand preferably has the relatively consistently thin slightly curved shape shown in FIG. 1 and the horizontal profile thereof preferably has the thicker bulbous profile shown in FIG. 2. When such a handle is properly grasped in the palm of the users hand, the users thumb will be at the top of the handle-forming portion 4a where it can operate the control member 10.

The front portion of the handle-forming portion 4a of the main elongated member 4 is provided with a rectangular elongated vertical opening 12 extending completely through the handle-forming portion 4a. The rectangular opening 12 is elongated in the direction of the length of the dilator device to provide a convenient opening in which the control member 10 may move during the operation thereof.

The control member 10 preferably has a circular segmental peripheral portion l0a with circumferentially spaced ribs 14 forming knurling which is engaged by the thumb of the user in rotating the control member. The control member has generally flat sides l0b-l0b which, for most of the extent thereof, are spaced apart a smaller distance than the width of the rectangular opening 12 so it can freely move therein. The index marks 12 may be embossed on or otherwise placed upon the sides 10b10b of the control member 10. At a point adjacent the French size index number for the fully collapsed condition of the dilator device, the sides of the control member are thickened at 10cl0c (see FIG. 10) to a point where the thickness of the control member is somewhat greater than the width of the rectangular opening 12 so that the control member will then be wedged in a locked condition within the opening 12.

Projecting laterally outwardly from the sides of the control member 10 are a pair of axially aligned pivotforming pins l717. As best shown in FIG. 11, on opposite sides of the rectangular opening 12 in the handle-forming portion 4a there are provided a pair of pivot pin-receiving openings 19-19 which open through inwardly tapering entryways 20-20 to the top of the handle-forming portion 4a. The pivot-forming pins l717 of the control member 10 snap into place within the openings 19-19 so the control member 10 is freely pivotally supported for movement within the rectangular opening 12. The front end portion of the periphery 10a of the control member 10 most desirably merges with a concave portion 10d which forms a convenient initial point of contact of the thumb with the control member when the control member is in its position shown in FIG. 3 where the dilator device is in its fully collapsed condition, as shown in FIG. 3 in dashed lines. The position of the users thumb when the dilator device is in its fully expanded condition is shown in dashed lines in FIG. 1.

The control member is provided with a segmental cylindrical opening 21 at a position roughly along a line extending between the pivot-forming pins 17 and the index marks showing the smallest French size. This opening 21 slidably receives a protuberant portion 6a at the rear end of the dilating bar 6.

The cross-sectional shape of the dilator bar 6 and the dilating bar-forming portion 4b of the main elongated member 4 is most advantageously like that shown most clearly in FIGS. 4 and 5. The cross-sectional shape for the dilator bar 6 will now be described, it being understood that the dilator bar-forming portion 4b has the identical shape although inverted with respect thereto. The dilator bar 6 has an outer peripheral surface 6b which falls along a circle whose center is positioned about midway between the dilator bar 6 and the dilator bar-forming portion 4b of the main elongated member 4 when the dilator bar 6 is spaced a maximum degree from the main elongated member 4, as shown in FIG. 1. The inner surface 6c of the dilator bar 6 is a flat surface which interconnects with the rounded outer peripheral surface 61) through rounded convex surfaces 6d-6d so the ends of the flat surface 6c is positioned inwardly of the sides of the dilator bar 6 to minimize the possibility of catching loose tissue when the dilator device is col-i lapsed within a passageway. The cross-sectional shape of the dilator bar 6 is elongated horizontally as viewed in FIG. 1, that is in the direction of the axis of rotation. of the control member 10, the length of the long axis thereof being much more than twice the short axis so that when the dilating member 6 is brought into con-1 tiguous relation with the dilator bar-forming portion 4b of the main elongated member 4 the overall cross-sectional profile of the collapsed dilator device is still an; elongated shape with the long axis at least about 1.5; times and most preferably twice the short axis of this overall configuration, as best shown in FIG. 5.

Each of the illustrated links 8 is generally square in shape when viewed in front or rear elevation (i.e. in a plane transverse to the longitudinal axis of the dilator device) and is very thin when viewed in side elevation, as shown in FIG. 1. The horizontal width of each of the links 8 is somewhat less than the corresponding; dimension or width of the dilating bar 6 and the dilator barforming portion 4b of the main elongated member 4. It can thus be seen that when the dilator device is fully collapsed, the flat inner surface 6c of the dilator bar 6 and the flat inner surface 25 of the dilator bar-forming portion 4b of the main elongated member 4 respectively make facial contact with the opposite sides of the various links 8 which then extend generally parallel to the length of the dilator device (see FIG. 9). These engaging surfaces are located inwardly of the side margins of the dilator device so the possibility of loose tissue being pinched by the collapsed dilator device is minimized.

As best shown in FIG. 8, the hinges at the ends of the links 8 are provided by a thinning of the synthetic plastic material out of which the dilator device is made, so that the dilator bar 6 and the dilator bar-forming portion 4b of the main elongated member 4 are respectively hingedly supported for movement about horizontal laterally extending pivot axes as viewed in the drawings.

In the preferred embodiment as illustrated, the forwardmost link 8' of the dilator device (FIG. 6), unlike the other links 8, is an initially forwardly curving element whose bottom end joins a constricted neck 27 of the tapered nose portion 40 and whose upper end merges with the forward end of the dilator bar 6. As shown in FIG. 7, when the dilator device is fully collapsed by the rearward longitudinal shifting of the dilator bar, the curved portion 8' is flattened so it extends longitudinally and merges smoothly with the nose portion 40.

The nose portion 40 of the dilator device tapers from its rear end to its forward end and is curved slightly upwardly as viewed in FIG. 1. This curved shape of the nose portion 40 is important in guiding the instrument through the male urethra. The dilator device 2, however, as illustrated, is also useful for insertion into a female urethra. It is sometimes necessary to attach a filiform member to aid in guiding the device through torturous paths in a diseased male urethra. Such a tiliform attachment is illustrated in FIGS. 13 and 14 and identified by reference numeral 30. To enable the attachment of the filiform attachment 30 to the end of the nose portion 40 a longitudinally extending threaded portion 32 is formed at the tip of the nose portion 4c. As best shown in FIG. 13, the threaded portion 32 is initially imperfectly threaded so the threading has a rounded profile wherein no sharp edges are presented which can scratch or cut the tissue of the urethra or other passageway involved as the nose and expandable portions of the dilator device are passed into and through the passageway involved. The diameter of the threaded portion 32 is substantially less than the diameter of the adjacent portion of the nose portion 4c so that when the end of the filiform attachment 30 is threaded around the threaded portion 32, the inner end of the filiform attachment will merge evenly with the end of the nose portion 40 of the dilator device.

As illustrated, the rear end of the filiform attachment 30 has a metal socket-forming member 34 attached to the main body of the filiform attachment which is made of a flexible synthetic plastic material such as polyethylene. The threaded portion 32 of the dilator device is made slightly oversized so that the threaded metal socket-forming portion 34 of the filiform attachment 30 will cut and sharpen or merely deform the margins of the threaded portion 32 to form a perfect thread when applied thereto, so the filiform attachment will be securely attached to the threaded portion 32.

It is apparent that the present invention provides a very inexpensive instrument for calibrating and dilating various human and animal passageways with safety and with a very fine degree of control.

It should be understood that numerous modifications may be made in the most preferred form of the invention described without deviating from the broader aspects of the invention.

We claim:

1. A dilator device for dilating constricted passageways in animals and humans, said device comprising: at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constricted passageway, links extending between and hinged at both ends thereof to said parallel bars at longitudinally spaced pivot points therealong for pivotal movement about pivot axes at right angles to the spacing of the bars, the links extending across the width of the bars and the lengths thereof being shorter than the spacings between the pivot points on each of the bars so the bars can be moved from relatively contiguous positions where the links are sandwiched between the bars without overlap in positions where they extend parallel to the bars, to relatively spaced apart positions where said passageway is dilated, said links when the bars are in their maximum spaced position being spaced apart a distance less than twice the length of the links to form a cage for holding loose tissue outside of the closely confronting surfaces of the bars when the bars are forced into their contiguous positions while in said constricted passageway, and means for moving said bars between said relatively contiguous and spaced apart positions.

2. The dilator device of claim 1 wherein said links when said bars are in said spaced apart positions are spaced apart a distance not greater than about the order of magnitude of the separation distance of said bars in said spaced apart positions.

3. The dilator device of claim 1 wherein the device is provided with handle means extending from one of the ends of the bars for grasping the dilator device, and means at the latter ends of the bars and in front of the handle means positioned to be operated by part of the same hand which grasps said handle means, selectively to move said bars between said relatively contiguous and spaced apart positions.

4. A dilator device for dilating constricted passageways in animals and humans, said device comprising: at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constructed passageway, links extending between and hinged at both ends thereof to said parallel bars at longitudinally spaced pivot points therealong for pivotal movement about pivot axes at right angles to the spacing of the bars, the lengths of the links being shorter than the spacings between the pivot points on each of the bars so the bars can be moved from relatively contiguous positions where the links are substantially sandwiched between the bars without overlap in positions where they extend parallel to the bars, to relatively spaced apart positions where said passageway is dilated, said bars having parallel confronting surfaces spaced from the longitudinal side margins of the bars by gradually rounded corners wherein the points at which the bars come close together when they are in their relatively contiguous position are located substantially inwardly of the longitudinal side margins of the bars, to minimize the possibility of pinching loose tissue between the bars.

5. A dilator device for dilating constricted passageways in animals and humans, said device comprising: only two relatively separable generally parallel bars separable transversely of one another and having confronting dilating portions adapted when brought into contiguous relation to be passed into a constricted passageway, the dilating portion of each of said bars having a substantially elongated cross-section in a direction transverse to the direction of relative movement thereof, so the long dimension thereof is much more than twice the shorter dimension transverse thereto, wherein said bars when in said relatively contiguous positions occupy an overall elongated space whose long axis extends in a direction transverse to the direction of the separation thereof and is at least about twice as long as its short axis, and means for moving said bars to relatively spaced apart positions where said constricted passageways will be expanded in the direction of the separation of the bars.

6. The dilator device of claim 5 wherein the opposite non-confronting exterior surfaces of said bars are rounded surfaces which fall approximately along the same circle when said bars are in substantially spaced apart passageway dilating positions.

7. The dilator device of claim 5 wherein said bars have parallel confronting surfaces spaced from the longitudinal side margins of the bars by gradually rounded corners wherein the points at which the bars come close together when they are in their relatively contiguous position are located substantially inwardly of the longitudinal side margins of the bars.

8. The dilator device of claim 5 wherein there is a flexible forwardly tapering nose portion in front of said bars for guiding the device into a human male or female urethra, and said bars being sized to enter and dilate a human male and female urethra.

9. A dilator device for dilating constrictive passageways in animal and humans, said device comprising at least two relatively separable generally parallel bars idapted when brought into contiguous relation to be assed into a constricted passageway, links extending between the confronting surfaces of and hinged to said arallel bars so the bars can be moved by the relative ongitudinal shifting thereof from relatively contiguous positions to spaced apart positions, said bars and said links being a single integrally molded synthetic plastic art where the hinges between the links and the bars are thin sections of plastic material, and manually operable means for moving said bars between said relatively contiguous and spaced apart positions.

10. The dilator device of claim 9 wherein said links extending between the bars are spaced so close together that they form a cage for holding loose tissue outside of the closely confronting surfaces of the bars when the bars are returned to their relatively contiguous positions while in said constricted passageway, said links having a length permitting separation of said bars to dilate said constricted passageway, and, when said bars are in said relatively contiguous positions, said links being sandwiched between the confronting surfaces of said bars and being in separated but closely contiguous relation.

11. The dilator device of claim 9 wherein said separable bars and links are molded in their spaced apart positions so the resiliency thereof urges the bars to their spaced apart positions, said manually operable means being mounted for normal unhindered movement so the operator can feel the opposition to the separation of the bars of the movement of said manually operable means, and means for holding said manually operable means in the position which adjust said bars to said contiguous positions so the device can be inserted into a constricted passageway without applying any force to said manually operable means.

12. The dilator device of claim 9 wherein there are only two relatively separable generally parallel bars where each bar has a substantially elongatedcross-section in a direction transverse to the direction of relative movement thereof, so the long dimension thereof is much more than twice the shorter dimension transverse thereto, said bars when in said relatively contiguous positions occupying an overall elongated space having a long axis at least about one and a half times as long as the short axis thereof, and said links being of such a length that when the bars are in said relatively maximum spaced apart positions the bars are separated an order of magnitude similar to the longest cross-sectional dimension of each of the bars, so the constricted passageway will then be expanded in the direction of separation of the bars.

13. A dilator device for dilating constricted passageways in animals and humans, said device comprising at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constricted passageway, said bars being separable to bring the same to maximum spaced apart positions where the passageway is dilated to a maximum degree thereby, said device having a forwardly tapering nose portion in the front of said relatively separable bars for guiding the device into and through said constricted passageway, and the front of said nose portion terminating in a longitudinally extending screw-threaded portion of less diameter than the contiguous end of the nose portion of the device and having rounded corners viewed in section to proi vide an imperfect screw thread so the screw-threade portion will not cut or injure said constricted passageway when pushed therethrough said screw thread being adapted to receive a tapered attachment of smaller size than said nose portion for forming tapered extension of the nose portion.

14. The dilator device of claim 13 in combinatio with said tapered attachment, said attachment having threaded socket of somewhat smaller size than sai screw-threaded portion of said dilator device and bein of a material which will form relatively sharp corner on said screw-threaded portion when threadeiil thereover, to form a secure interconnection betwee the nose portion of the dilator device and the attachment.

IS. A dilator device for dilating constricted passageways in animals and humans, said device comprising: a first elongated member having a dilating portion adapted to enter the constricted passageway to be dilated and a handle-forming portion forming a rigid longitudinal extension of the rear end of said dilating portion, said handle-forming portion of said first elongated member adapted to be firmly heid in the palm of one hand of the user with the thumb thereof pointing forwardly along the length of the member and free to manipulate the device, a second elongated member having a dilating portion also adapted to enter said constricted passageway to be dilated and confronting and extending generally parallel to said dilating portion of said first member on the side thereof on which said thumb will extend, links interconnecting said second elongated member and the passageway dilating portion of said first member and pivoted thereto along lateral transverse axes so the longitudinal shifting of said second elongated member will move the second member from a position immediately contiguous to said passageway dilating portion of said first member to a position where it is spaced a relatively large distance therefrom, and operating means connected to the rear end of said second member which means is engageable by the thumb of the hand grasping the handle-forming portion of said first member when said second member is contiguous to said passageway dilating portion of said first member and is forwardly pushable thereby to shift said second member longitudinally forwardly to bring the same into said position where said second member is substantially spaced therefrom.

16. A dilator device for dilating constricted passageways in animals and humans, said device comprising: a first elongated member having a dilating portion adapted to enter the constricted passageway to be dilated and a handle-forming portion forming a rigid extension of the rear end of said dilating portion, said handle-forming portion of said first elongated member adapted to be firmly held in the palm of one hand of the user with the thumb thereof pointing forwardly along the length of the member and free to manipulate the device, a second elongated member having a dilating portion also adapted to enter said constricted passageway to be dilated and confronting and extending generally parallel to said dilating portion of said first member on the side thereof on which said thumb will extend, links interconnecting said second elongated member and the passageway dilating portion of said first member and pivoted thereto along lateral transverse axes so the longitudinal shifting of said second elongated member will move the second member from a position immediately contiguous to said passageway dilating portion of said first member to a position where it is spaced a relatively large distance therefrom, and operating means connected to the rear end of said second member which means is engageable by the thumb of the hand grasping the handle-forming portion of said first member when said second member is contiguous to said passageway dilating portion of said first member and is forwardly pushable thereby to shift said second member longitudinally forwardly to bring the same into said position where said second member is substantially spaced therefrom, said operating means being a control member pivotally mounted on said first member for movement about a lateral transverse axis parallel to the hinge axes of said links, said second member being connected to said rotatable control member at a point spaced rearwardly of the axis of rotation of said rotatable control member when said second member is contiguous to said passageway dilating portion of said first member so the bars are separated by pushing on the control member.

17. The dilator device of claim 16 wherein the point of connection of said second member to said rotatable control member when said second member is contiguous to said passageway dilating portion of said first member is on or adjacent to a line extending through the axis of rotation of said rotatable control member and generally parallel to the length of the dilator- 18. The dilator device of claim 16 wherein said first member includes a forward extension in front of the forwardmost portion of said second member, which extension is forwardly tapered and is relatively flexible for aiding in guiding the dilator device into and through a constricted passageway.

19. The dilator device of claim 16 wherein said rotatable control member has calibrated index marks thereon which passes opposite a portion of said first member and indicates the degree of separation of said second member relative to the passageway dilating portion of said first member.

20. A dilator device for dilating constricted passageways in a male urethra, said device comprising at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a male urethra, handle means at the rear end of the bars for holding the device, said bars being separable to bring the same to a maximum spaced apart position where the urethra is dilated thereby, said device having a forwardly tapering and laterally curving flexible nose portion in the front of said relatively separable bars for guiding the device into said male urethra, said flexible nose portion being a longitudinal extension on the front end of one of the bars and at the inner end thereof projects laterally beyond the side of the latter bar confronting the other bar so the periphery of the tapering nose portion smoothly merges with the periphery of both of the bars when the bars are brought into contiguous relation.

21. The dilator device of claim 15 wherein there is a forwardly tapering nose portion in front of one of said members for guiding the device into a human male or female urethra, and said members are sized to enter and dilate a human male and female urethra. 

1. A dilator device for dilating constricted passageways in animals and humans, said device comprising: at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constricted passageway, links extending between and hinged at both ends thereof to said parallel bars at longitudinally spaced pivot points therealong for pivotal movement about pivot axes at right angles to the spacing of the bars, the links extending across the width of the bars and the lengths thereof being shorter than the spacings between the pivot points on each of the bars so the bars can be moved from relatively contiguous positions where the links are sandwiched between the bars without overlap in positions where they extend parallel to the bars, to relatively spaced apart positions where said passageway is dilated, said links when the bars are in their maximum spaced position being spaced apart a distance less than twice the length of the links to form a cage for holding loose tissue outside of the closely confronting surfaces of the bars when the bars are forced into their contiguous positions while in said constricted passageway, and means for moving said bars between said relatively contiguous and spaced apart positions.
 2. The dilator device of claim 1 wherein said links when said bars are in said spaced apart positions are spaced apart a distance not greater than about the order of magnitude of the separation distance of said bars in said spaced apart positions.
 3. The dilator device of claim 1 wherein the device is provided with handle means extending from one of the ends of the bars for grasping the dilator device, and means at the latter ends of the bars and in front of the handle means positioned to be operated by part of the same hand which grasps said handle means, selectively to move said bars between said relatively contiguous and spaced apart positions.
 4. A dilator device for dilating constricted passageways in animals and humans, said device comprising: at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constructed passageway, links extending between and hinged at both ends thereof to said parallel bars at longitudinally spaced pivot points therealong for pivotal movement about pivot axes at right angles to the spacing of the bars, the lengths of the links being shorter than the spacings between the pivot points on each of the bars so the bars can be moved from relatively contiguous positions where the links are substantially sandwiched between the bars without overlap in positions where they extend parallel to the bars, to relatively spaced apart positions where said passageway is dilated, said bars having parallel confronting surfaces spaced from the longitudinal side margins of the bars by gradually rounded corners wherein the points at which the bars come close together when they are in their relatively contiguous position are located substantially inwardly of the longitudinal side margins of the bars, to minimize the possibility of pinching loose tissue between the bars.
 5. A dilator device for dilating constricted passageways in animals and humans, said device comprising: only two relatively separable generally parallel bars separable transversely of one another and having confronting dilating portions adapted when brought into contiguous relation to be passed into a constricted passageway, the dilating portion of each of said bars having a substantially elongated cross-section in a direction transverse to the direction of relative movement thereof, so the long dimension thereof is much more than twice the shorter dimension transverse thereto, wherein said bars when in said relatively contiguous positions occupy an overall elongated space whose long axis extends in a direction transverse to the direction of the separation thereof and is at least about twice as long as its short axis, and means for moving said bars to relatively spaced apart positions where said constricted passageways will be expanded in the direction of the separation of the bars.
 6. The dilator device of claim 5 wherein the opposite non-confronting exterior surfaces of said bars are rounded surfaces which fall approximately along the same circle when said bars are in substantially spaced apart passageway dilating positions.
 7. The dilator device of claim 5 wherein said bars have parallel confronting surfaces spaced from the longitudinal side margins of the bars by gradually rounded corners wherein the points at which the bars come close together when they are in their relatively contiguous position are located substantially inwardly of the longitudinal side margins of the bars.
 8. The dilator device of claim 5 wherein there is a flexible forwardly tapering nose portion in front of said bars for guiding the device into a human male or female urethra, and said bars being sized to enter and dilate a human male and female urethra.
 9. A dilator device for dilating constrictive passage-ways in animal and humans, said device comprising at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constricted passageway, links extending between the confronting surfaces of and hinged to said parallel bars so the bars can be moved by the relative longitudinal shifting thereof from relatively contiguous positions to spaced apart positions, said bars and said links being a single integrally molded synthetic plastic part where the hinges between the links and the bars are thin sections of plastic material, and manually operable means for moving said bars between said relatively contiguous and spaced apart positions.
 10. The dilator device of claim 9 wherein said links extending between the bars are spaced so close together that they form a cage for holding loose tissue outside of the closely confronting surfaces of the bars when the bars are returned to their relatively contiguous positions while in said constricted passageway, said links having a length permitting separation of said bars to dilate said constricted passageway, and, when said bars are in said relatively contiguous positions, said links being sandwiched between the confronting surfaces of said bars and being in separated but closely contiguous relation.
 11. The dilator device of claim 9 wherein said separable bars and links are molded in their spaced apart positions so the resiliency thereof urges the bars to their spaced apart positions, said manually operable means being mounted for normal unhindered movement so the operator can feel the opposition to the separation of the bars of the movement of said manually operable means, and means for holding said manually operable means in the position which adjust said bars to said contiguous positions so the device can be inserted into a constricted passageway without applying any force to said manually operable means.
 12. The dilator device of claim 9 wherein there are only two relatively separable generally parallel bars where each bar has a substantially elongated cross-section in a direction transverse to the direction of relative movement thereof, so the long dimension thereof is much more than twice the shorter dimension transverse thereto, said bars when in said relatively contiguous positions occupying an overall elongated space having a long axis at least about one and a half times as long as the short axis thereof, and said links being of such a length that when the bars are in said relatively maximum spaced apart positions the bars are separated an order of magnitude similar to the longest cross-sectional dimension of each of the bars, so the constricted passageway will then be expanded in the direction of separation of the bars.
 13. A dilator device for dilating constricted passageways in animals and humans, said device comprising at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a constricted passageway, said bars being separable to bring the same to maximum spaced apart positions where the passageway is dilated to a maximum degree thereby, said device having a forwardly tapering nose portion in the front of said relatively separable bars for guiding the device into and through said constricted passageway, and the front of said nose portion terminating in a longitudinally extending screw-threaded portion of less diameter than the contiguous end of the nose portion of the device and having rounded corners viewed in section to provide an imperfect screw thread so the screw-threaded portion will not cut or injure said constricted passageway when pushed therethrough said screw thread being adapted to receive a tapered attachment of smaller size than said nose portion for forming a tapered extension of the nose portion.
 14. The dilator device of claim 13 in combination with said tapered attachment, said attachment having a threaded socket of somewhat smaller size than said screw-threaded portion of said dilator device and being of a material which will form relatively sharp corners on said screw-threaded portion when threaded thereover, to form a secure interconnection between the nose portion of the dilator device and the attachment.
 15. A dilator device for dilating constricted passageways in animals and humans, said device comprising: a first elongated member having a dilating portion adapted to enter the constricted passageway to be dilated and a handle-forming portion forming a rigid longitudinal extension of the rear end of said dilating portion, said handle-forming portion of said first elongated member adapted to be firmly held in the palm of one hand of the user with the thumb thereof pointing forwardly along the length of the member and free to manipulate the device, a second elongated member having a dilating portion also adapted to enter said constricted passageway to be dilated and confronting and extending generally parallel to said dilating portion of said first member on the side thereof on which said thumb will extend, links interconnecting said second elongated member and the passageway dilating portion of said first member and pivoted thereto along lateral transverse axes so the longitudinal shifting of said second elongated member will move the second member from a position immediately contiguous to said passageway dilating portion of said first member to a position where it is spaced a relatively large distance therefrom, and operating means connected to the rear end of said second member which means is engageable by the thumb of the hand grasping the handle-forming portion of said first member when said second member is contiguous to said passageway dilating portion of said first member and is forwardly pushable thereby to shift said second member longitudinally forwardly to bring the same into said position where said second member is substantially spaced therefrom.
 16. A Dilator device for dilating constricted passageways in animals and humans, said device comprising: a first elongated member having a dilating portion adapted to enter the constricted passageway to be dilated and a handle-forming portion forming a rigid extension of the rear end of said dilating portion, said handle-forming portion of said first elongated member adapted to be firmly held in the palm of one hand of the user with the thumb thereof pointing forwardly along the length of the member and free to manipulate the device, a second elongated member having a dilating portion also adapted to enter said constricted passageway to be dilated and confronting and extending generally parallel to said dilating portion of said first member on the side thereof on which said thumb will extend, links interconnecting said second elongated member and the passageway dilating portion of said first member and pivoted thereto along lateral transverse axes so the longitudinal shifting of said second elongated member will move the second member from a position immediately contiguous to said passageway dilating portion of said first member to a position where it is spaced a relatively large distance therefrom, and operating means connected to the rear end of said second member which means is engageable by the thumb of the hand grasping the handle-forming portion of said first member when said second member is contiguous to said passageway dilating portion of said first member and is forwardly pushable thereby to shift said second member longitudinally forwardly to bring the same into said position where said second member is substantially spaced therefrom, said operating means being a control member pivotally mounted on said first member for movement about a lateral transverse axis parallel to the hinge axes of said links, said second member being connected to said rotatable control member at a point spaced rearwardly of the axis of rotation of said rotatable control member when said second member is contiguous to said passageway dilating portion of said first member so the bars are separated by pushing on the control member.
 17. The dilator device of claim 16 wherein the point of connection of said second member to said rotatable control member when said second member is contiguous to said passageway dilating portion of said first member is on or adjacent to a line extending through the axis of rotation of said rotatable control member and generally parallel to the length of the dilator device, whereby the variation in the spacing of said second member from the passageway dilating portion of said first member forms a roughly linear function with the angle of rotation of said rotatable control member.
 18. The dilator device of claim 16 wherein said first member includes a forward extension in front of the forwardmost portion of said second member, which extension is forwardly tapered and is relatively flexible for aiding in guiding the dilator device into and through a constricted passageway.
 19. The dilator device of claim 16 wherein said rotatable control member has calibrated index marks thereon which passes opposite a portion of said first member and indicates the degree of separation of said second member relative to the passageway dilating portion of said first member.
 20. A dilator device for dilating constricted passageways in a male urethra, said device comprising at least two relatively separable generally parallel bars adapted when brought into contiguous relation to be passed into a male urethra, handle means at the rear end of the bars for holding the device, said bars being separable to bring the same to a maximum spaced apart position where the urethra is dilated thereby, said device having a forwardly tapering and laterally curving flexible nose portion in the front of said relatively separable bars for guiding the device into said male urethra, said flexible nose portion being a longitudinal extension on the front end of one of the bars and at the inner end thereOf projects laterally beyond the side of the latter bar confronting the other bar so the periphery of the tapering nose portion smoothly merges with the periphery of both of the bars when the bars are brought into contiguous relation.
 21. The dilator device of claim 15 wherein there is a forwardly tapering nose portion in front of one of said members for guiding the device into a human male or female urethra, and said members are sized to enter and dilate a human male and female urethra. 